STABILITY-INDICATING LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF PENTOXYVERINE CITRATE AND ITS DEGRADANT
Objectives: The objectives of this research were to develop and validate a HPLC method for determination of Pentoxyverine citrate (PNX) and its degradant (DG).
Methods: Forced degradation studies were performed on bulk sample using alkaline (0.1M sodium hydroxide) and acid (1M hydrochloric acid. The proposed method was based on using a 150 x 4.6 mm (i. d.) (Luna, Phenomenex, Torrance, CA, USA) (5 Âµm particle size) reversed phase C18 column with mobile phase consisting of a mixture of methanol-10 mM sodium dihydrogen phosphate pH 4 in ratio of (60:40, v/v) and UV detection at 230 nm with flow rate of 1 mL min-1.
Results: The linear calibration range was between 10-40 mg ml-1and 10-40 mg ml-1for PNX and DG respectively. The method was found to be accurate with 100.23% and 100.07% recovery for PNX and DG respectively. The limit of detection (LOD) was found to be 3.79 x10-2Î¼g ml-1 and 4.24 x10-2Î¼g ml-1 for PNX and DG respectively, while the limit of quantification (LOQ) was found to be 12.62 x10-2Î¼g ml-1 and 14.12 x10-2Î¼g ml-1 for PNX and DG respectively. PNX was found to be most stable at a pH of 5.7.
Conclusion: The validation study of the proposed method was successfully carried out and the method was found to be suitable and economic for routine determination of PNX in pharmaceutical syrup, without any interference from the excipients, and in the presence of its acidic and alkaline degradation products.
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